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Tiapride (Tablets, Solution) Instructions for Use

ATC Code

N05AL03 (Tiapride)

Active Substance

Tiapride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacotherapeutic Group

Psycholeptics; antipsychotics; benzamides

Pharmacological Action

Antipsychotic agent (neuroleptic) from the group of substituted benzamides. The antipsychotic action is due to the blockade of dopamine D2 receptors in the mesolimbic or mesocortical system.

It has an analgesic effect in interoceptive and exteroceptive pain. It has a sedative effect, due to the blockade of adrenoreceptors of the brainstem reticular formation; an antiemetic effect, associated with the blockade of dopamine D2 receptors of the trigger zone of the vomiting center; and a hypothermic effect, due to the blockade of dopamine receptors in the hypothalamus.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is reached after 1 hour. Plasma protein binding is low. It penetrates the blood-brain barrier. T1/2 is 3-4 hours. It is excreted by the kidneys predominantly unchanged.

In renal insufficiency, the elimination of tiapride from the body is slowed down.

Indications

Agitation, aggressiveness, especially in chronic alcoholism, in the elderly; therapy-resistant, severe pain syndrome; chorea, tics in Tourette’s disease, severe behavioral disorders accompanied by aggressiveness and agitation.

ICD codes

ICD-10 code Indication
F10 Mental and behavioral disorders due to alcohol use
F91 Conduct disorders
F95.2 Combining vocalizations and multiple motor tics [de la Tourette's syndrome]
G25.5 Other chorea
R45.1 Restlessness and agitation
R52.0 Acute pain
R52.2 Other chronic pain
ICD-11 code Indication
6C40.Z Disorders due to alcohol use, unspecified
6C91.Z Dissocial behavioral disorder, unspecified
8A01.0 Benign hereditary chorea
8A01.2Z Hemichorea or hemiballismus, unspecified
8A05.00 Tourette's syndrome
8A0Z Motor impairments, unspecified
MB24.F Restlessness
MG30.Z Chronic pain syndrome, unspecified
MG31.Z Acute pain, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Determine the dosage individually based on indication, patient age, and clinical status.

For agitation and aggressiveness in chronic alcoholism, administer 300 mg to 1200 mg per day in divided doses.

For agitation and behavioral disorders in the elderly, initiate therapy with a lower dose of 100 mg to 300 mg daily.

For severe, therapy-resistant pain, use a dosage of 300 mg to 600 mg daily.

For chorea and tics in Tourette’s disease, administer 300 mg to 600 mg per day.

Adjust the total daily dose based on therapeutic response and tolerability.

Divide the total daily dose into two or three administrations.

For renal impairment, reduce the dosage due to slowed elimination; monitor patients closely.

For elderly patients, initiate treatment at the lower end of the dosage range.

Do not exceed the maximum recommended daily dose without medical supervision.

Adverse Reactions

From the central nervous system: drowsiness, sleep disorders, agitation, apathy, dizziness, headaches, parkinsonian syndrome; rarely – spasmodic torticollis, oculogyric crises, akathisia, tardive dyskinesia; in some cases – neuroleptic malignant syndrome.

From the endocrine system: rarely – symptoms caused by hyperprolactinemia (amenorrhea, galactorrhea, breast enlargement, breast pain, impotence, orgasm disorders).

From the cardiovascular system: QT interval prolongation, orthostatic hypotension; in some cases – torsades de pointes arrhythmias.

Contraindications

Presence or suspicion of prolactin-dependent tumors, pheochromocytoma; hypersensitivity to tiapride.

Use in Pregnancy and Lactation

During pregnancy, Tiapride is used only for absolute indications in the minimum effective doses. Newborns whose mothers received Tiapride during pregnancy are recommended to be monitored for CNS and gastrointestinal functions.

It is not known whether Tiapride is excreted in breast milk. If use during lactation is necessary, breastfeeding should be discontinued.

Use in Renal Impairment

Use with caution in renal insufficiency.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with particular caution in patients with epilepsy due to a possible decrease in the seizure threshold.

Use with caution in severe cardiovascular diseases, parkinsonism, renal insufficiency, and also in elderly patients.

Parenteral administration should be carried out under medical supervision.

During treatment with tiapride, levodopa, dopamine receptor agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide), sultopride should not be used; medicinal products that can cause torsades de pointes arrhythmias (antiarrhythmic drugs of classes I A and III, chlorpromazine, levomepromazine, thioridazine, trifluoperazine, sultopride, droperidol, haloperidol, pimozide, bepridil, cisapride, difemanil, erythromycin for intravenous administration, vincamine for intravenous administration, as well as halofantrine, morfloxacin, pentamidine, sparfloxacin).

Avoid alcohol consumption.

Influence on the ability to drive vehicles and operate machinery

Use with caution in patients whose activities require concentration and high speed of psychomotor reactions.

Drug Interactions

With simultaneous use of drugs that depress the central nervous system (including opioid analgesics, antihistamines, barbiturates, benzodiazepines), an enhancement of the depressant effect on the central nervous system is possible.

With simultaneous use of antihypertensive drugs, an enhancement of the hypotensive effect is possible.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Tiapride Tablets 100 mg: 10, 20, 30, 40, 50, 60, 90, 120, 150 or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a cross score.

1 tab.
Tiapride hydrochloride 111.1 mg,
   Equivalent to tiapride content 100 mg

Excipients: microcrystalline cellulose (MCC-101 Premium) – 37.7 mg, microcrystalline cellulose (MCC-102) – 18 mg, croscarmellose sodium – 5.4 mg, magnesium stearate – 2.7 mg, colloidal silicon dioxide – 2.7 mg, povidone K25 – 2.4 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (4) – cardboard packs.
30 pcs. – blister packs (5) – cardboard packs.
30 pcs. – blister packs (10) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Tiapride Tablets 100 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Tiapride (as hydrochloride) 100 mg

30 pcs. – dark glass jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Form

Bottle Rx Icon Tiapride Solution for intravenous and intramuscular administration 100 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration 1 ml 1 amp.
Tiapride (as hydrochloride) 50 mg 100 mg

2 ml – ampoules (5) – plastic contour packs (2) – cardboard packs.
2 ml – ampoules (10) – cardboard packs (1).

Marketing Authorization Holder

Endocrine Technologies, LLC (Russia)

Manufactured By

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle Rx Icon Tiapride Solution for intravenous and intramuscular administration 50 mg/1 ml: amp. 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration transparent, colorless.

1 ml 1 amp.
Tiapride (as hydrochloride) 50 mg 100 mg

Excipients: sodium chloride, sodium hydroxide solution 0.1M (for pH correction), water for injections.

2 ml – ampoules (5) – blister packs (1) – cardboard packs.
2 ml – ampoules (5) – blister packs (2) – cardboard packs.

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